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Analysis from a 10-month post-launch evaluation of the REMS Program finds 2.8% incidence of LVEF <50% in over 1500 patients, strengthening the safety pro CAMZYOS® (mavacamten) for NYHA class II-III obstructive hypertrophic cardiomyopathy Real-world data reaffirm therapeutic value and treatment benefit of CAMZYOS in improving cardiac symptoms and NYHA class in patients with obstructive hypertrophic cardiomyopathy PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb Company (NYSE: BMY) today announced the presentation of data at the American College of Cardiology (ACC) Annual Scientific Session & Expo, taking place April 6-8, 2024 in Atlanta, Georgia. “The therapeutic benefit of CAMZYOS in real-world practice, demonstrated by our data at ACC, builds on the well-established clinical program and further underscores the importance of this transformational medicine which is the first and only approved cardiac myosin inhibitor. With thousands of patients around the world treated to date, CAMZYOS is redefining the treatment landscape for this patient population and may offer hope to countless others moving forward,” said Roland Chen, MD, Senior Vice President and Head of Development, Immunology, Cardiovascular & Neurology. “In addition to showcasing our growing body of real-world evidence and safety data for CAMZYOS at ACC, we look forward to highlighting additional data from our cardiovascular portfolio, including an analysis of the real-world clinical impact of ELIQUIS.” Research to be presented at the meeting supports the robust safety and clinical pro CAMZYOS® (mavacamten) and compliance with the Risk Evaluation and Mitigation Strategy (REMS) Program. These data include: An analysis of results from the 10-month post-launch evaluation of the CAMZYOS REMS Program in 1,524 patients with patient status forms submitted, which demonstrated that approximately 1% (n=17) of patients reported clinical heart failure requiring hospitalization and 2.8% (n=43) of patients reported a decrease in left ventricular ejection fraction (LVEF) to <50%. These data are consistent with the clinical development program and reinforce the safety pro CAMZYOS in clinical practice. These data (abstract 1075-07) will be featured as a moderated poster on Sunday, April 7 from 1:30 PM – 1:40 PM ET. A single-center real-world experience analysis of 53 patients treated with CAMZYOS which found that at 24 weeks, CAMZYOS led to improvements in cardiovascular symptoms (96%) and improvements in one or more New York Heart Association (NYHA) class (49%). Additionally, resting and Valsalva LVOT gradient decreased during the first four weeks after starting treatment, with statistically significant reductions from baseline at week 24 (P<0.001). No patients required cessation of treatment due to reduction of LVEF to <50% or other side effects, though two patients required temporary drug discontinuation due to Valsalva LVOT gradient less than 20 mmHg during the 24-week treatment period. These data (abstract 1424-134) will be featured as a poster on Sunday, April 7 from 1:15 PM – 2:00 PM ET. The BMS-Pfizer Alliance will also present research at the meeting that adds to the robust body of evidence pertaining to the safety and efficacy pro ELIQUIS® (apixaban). These data include: A real-world evidence study of non-valvular atrial fibrillation (NVAF) patients on Medicare previously treated with warfarin and switched to a direct oral anticoagulant (DOAC: apixaban, dabigatran, or rivaroxaban), which found that those who received ELIQUIS had a statistically significant lower risk of stroke/systemic embolism (S/SE) and major bleeding (MB) than those patients who received rivaroxaban (S/SE HR: 0.91; 95% CI: 0.85-0.97 and MB HR: 0.68; 95% CI: 0.65-0.72) or dabigatran (S/SE HR: 0.83; 95% CI: 0.72-0.96 and MB HR: 0.79; 95% CI: 0.71-0.89). This pairwise comparative analysis provides the rates of S/SE and MB shown in patients with NVAF on Medicare associated with switching from warfarin to different DOACs. This effectiveness and safety information about ELIQUIS use in clinical practice can supplement data from randomized clinical trials. These data (abstract 1306-157) will be featured as a poster on Saturday, April 6 from 2:45 PM – 3:00 PM ET. Select BMS and BMS-Pfizer Alliance-sponsored abstracts to be presented at ACC can be found below. Complete abstracts may be accessed online here. Visit this page on BMS.com for more information on Bristol Myers Squibb’s scientific approach and resources on cardiovascular diseases. Abstract Title Primary Author Type/# Session Title Time (ET) Saturday, April 6, 2024 The experiences, values and goals of people in Australia living with obstructive hypertrophic cardiomyopathy: In-depth patient interviews Fifer, S. Poster – 1244-128 1244 - Heart Failure and Cardiomyopathies: Basic and Translational Science 03 11:45 AM – 12:30 PM Effect of mavacamten on health status in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy: Results from the EXPLORER-CN study Tian, Z. Poster – 1284-132 1284 - Heart Failure and Cardiomyopathies: Pharmacology 05 1:45 PM – 2:30 PM Evaluation of effectiveness and safety outcomes among Medicare patients with non-valvular atrial fibrillation who switched from warfarin to direct oral anticoagulants* Atreja, N. Poster – 1306-157 1306 - Ischemic Heart Disease: Special Populations 06 2:45 PM – 3:30 PM Sunday, April 7, 2024 Greatest absolute benefit of apixaban and limiting aspirin is in those with comorbidity: Results from the AUGUSTUS trial* Krychtiuk, K. Poster – 1065-11 1065 - Vascular Vistas: Tailored Research for Special Populations 12:00 PM – 12:10 PM Real-world experience and 24-week outcomes of patients with symptomatic obstructive hypertrophic cardiomyopathy treated with mavacamten in the US Reza, N. Poster – 1424-134 1424 - Heart Failure and Cardiomyopathies: Special Populations 12 1:15 PM – 2:00 PM The CAMZYOS (mavacamten) risk evaluation and mitigation strategy program: Results from 10 months post-launch Martinez, M. Poster – 1075-07 1075 - Bulking Up: Advances in Hypertrophic Cardiomyopathy 1:30 PM – 1:40 PM Effects of mavacamten on circulating biomarkers in obstructive hypertrophic cardiomyopathy: Insights from the EXPLORER-HCM study using comprehensive proteomics profiling Wang, Z. Poster – 1075-09 1075 - Bulking Up: Advances in Hypertrophic Cardiomyopathy 1:45 PM – 1:55 PM *Sponsored by the Bristol Myers Squibb-Pfizer Alliance About CAMZYOS® (mavacamten) CAMZYOS® (mavacamten) is the first and only cardiac myosin inhibitor approved in the U.S., indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms, and in the European Union, indicated for the treatment of symptomatic (NYHA, class II-III) obstructive HCM in adult patients. It has also received regulatory approvals on five continents including in Argentina, Australia, Brazil, Canada, Great Britain, Hong Kong, Israel, Singapore, South Korea, and Switzerland. CAMZYOS is an allosteric and reversible inhibitor selective for cardiac myosin. CAMZYOS modulates the number of myosin heads that can enter “on actin” (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridge formation. Excess myosin actin cross-bridge formation and dysregulation of the super-relaxed state are mechanistic hallmarks of HCM. CAMZYOS shifts the overall myosin population towards an energy-sparing, recruitable, super-relaxed state. In HCM patients, myosin inhibition with CAMZYOS reduces dynamic left ventricular outflow tract (LVOT) obstruction and improves cardiac filling pressures. IMPORTANT SAFETY INFORMATION WARNING: RISK OF HEART FAILURE CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Interrupt CAMZYOS if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status. Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with the following: Moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers Because of the risk of heart failure due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CAMZYOS REMS PROGRAM. CONTRAINDICATIONS CAMZYOS is contraindicated with concomitant use of: Moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers WARNINGS AND PRECAUTIONS Heart Failure CAMZYOS reduces systolic contraction and can cause heart failure or totally block ventricular function. Patients who experience a serious intercurrent illness (e.g., serious infection) or arrhythmia (e.g., atrial fibrillation or other uncontrolled tachyarrhythmia) are at greater risk of developing systolic dysfunction and heart failure. Assess the patient’s clinical status and LVEF prior to and regularly during treatment and adjust the CAMZYOS dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, palpitations, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide (NT-proBNP) may be signs and symptoms of heart failure and should also prompt an evaluation of cardiac function. Asymptomatic LVEF reduction, intercurrent illnesses, and arrhythmias require additional dosing considerations. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited. CYP 450 Drug Interactions Leading to Heart Failure or Loss of Effectiveness CAMZYOS is primarily metabolized by CYP2C19 and CYP3A4 enzymes. Concomitant use of CAMZYOS and drugs that interact with these enzymes may lead to life-threatening drug interactions such as heart failure or loss of effectiveness. Advise patients of the potential for drug interactions, including with over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine). Advise patients to inform their healthcare provider of all concomitant products prior to and during CAMZYOS treatment. CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program CAMZYOS is only available through a restricted program called the CAMZYOS REMS Program because of the risk of heart failure due to systolic dysfunction. Notable requirements of the CAMZYOS REMS Program include the following: Prescribers must be certified by enrolling in the REMS Program. Patients must enroll in the REMS Program and comply with ongoing monitoring requirements. Pharmacies must be certified by enrolling in the REMS Program and must only dispense to patients who are authorized to receive CAMZYOS. Wholesalers and distributors must only distribute to certified pharmacies. Further information is available at or by telephone at 1-833-628-7367. Embryo-Fetal Toxicity CAMZYOS may cause fetal toxicity when administered to a pregnant female, based on animal studies. Confirm absence of pregnancy in females of reproductive potential prior to treatment and advise patients to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. CAMZYOS may reduce the effectiveness of combined hormonal contraceptives (CHCs). Advise patients using CHCs to use an alternative contraceptive method that is not affected by CYP 450 enzyme induction or to add nonhormonal contraception. Advise females of reproductive potential about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy. ADVERSE REACTIONS In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%). There were no new adverse reactions identified in VALOR-HCM. Effects on Systolic Function In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS. DRUG INTERACTIONS Potential for Other Drugs to Affect Plasma Concentrations of CAMZYOS CAMZYOS is primarily metabolized by CYP2C19 and to a lesser extent by CYP3A4 and CYP2C9. Inducers and inhibitors of CYP2C19 and moderate to strong inhibitors or inducers of CYP3A4 may affect the exposures of CAMZYOS. Impact of Other Drugs on CAMZYOS: Moderate to Strong CYP2C19 Inhibitors or Strong CYP3A4 Inhibitors: Concomitant use increases CAMZYOS exposure, which may increase the risk of heart failure due to systolic dysfunction. Concomitant use is contraindicated. Moderate to Strong CYP2C19 Inducers or Moderate to Strong CYP3A4 Inducers: Concomitant use decreases CAMZYOS exposure, which may reduce CAMZYOS’ efficacy. The risk of heart failure due to systolic dysfunction may increase with discontinuation of these inducers as the levels of induced enzyme normalizes. Concomitant use is contraindicated. Weak CYP2C19 Inhibitors or Moderate CYP3A4 Inhibitors: Concomitant use with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor increases CAMZYOS exposure, which may increase the risk of adverse drug reactions. Initiate CAMZYOS at the recommended starting dose of 5 mg orally once daily in patients who are on stable therapy with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Reduce dose of CAMZYOS by one level (i.e., 15 to 10 mg, 10 to 5 mg, or 5 to 2.5 mg) in patients who are on CAMZYOS treatment and intend to initiate a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Schedule clinical and echocardiographic assessment 4 weeks after inhibitor initiation, and do not up-titrate CAMZYOS until 12 weeks after inhibitor initiation. Avoid initiation of concomitant weak CYP2C19 and moderate CYP3A4 inhibitors in patients who are on stable treatment with 2.5 mg of CAMZYOS because a lower dose is not available. Potential for CAMZYOS to Affect Plasma Concentrations of Other Drugs CAMZYOS is an inducer of CYP3A4, CYP2C9, and CYP2C19. Concomitant use with CYP3A4, CYP2C19, or CYP2C9 substrates may reduce plasma concentration of these drugs. Closely monitor when CAMZYOS is used in combination with CYP3A4, CYP2C19, or CYP2C9 substrates where decreases in the plasma concentration of these drugs may reduce their activity. Hormonal Contraceptives: Progestin and ethinyl estradiol are CYP3A4 substrates. Concomitant use of CAMZYOS may decrease exposures of ethinyl estradiol and progestin, which may lead to contraceptive failure or an increase in breakthrough bleeding. Advise patients to use a contraceptive method that is not affected by CYP 450 enzyme induction (e.g., intrauterine system) or add nonhormonal contraception (such as condoms) during concomitant use and for 4 months after the last dose of CAMZYOS. Drugs That Reduce Cardiac Contractility Expect additive negative inotropic effects of CAMZYOS and other drugs that reduce cardiac contractility. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited. If concomitant therapy with a negative inotrope is initiated, or if the dose of a negative inotrope is increased, monitor LVEF closely until stable doses and clinical response have been achieved. SPECIFIC POPULATIONS Pregnancy CAMZYOS may cause fetal harm when administered to a pregnant female. Advise pregnant females about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy. There is a pregnancy safety study for CAMZYOS. If CAMZYOS is administered during pregnancy, or if a patient becomes pregnant while receiving CAMZYOS or within 4 months after the last dose of CAMZYOS, healthcare providers should report CAMZYOS exposure by contacting Bristol Myers Squibb at 1-800-721-5072 or . Lactation The presence of CAMZYOS in human or animal milk, the drug’s effects on the breastfed infant, or the effects on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CAMZYOS and any potential adverse effects on the breastfed child from CAMZYOS or from the underlying maternal condition. Females and Males of Reproductive Potential Confirm absence of pregnancy in females of reproductive potential prior to initiation of CAMZYOS. Advise females of reproductive potential to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. Use of CAMZYOS may reduce the effectiveness of CHCs. Advise patients using CHCs to use an alternative contraceptive method or add nonhormonal contraception. Please see U.S. Full Prescribing Information, including Boxed WARNING and Medication Guide. About ELIQUIS ® (apixaban) ELIQUIS® is an oral selective Factor Xa inhibitor. By inhibiting Factor Xa, a key blood clotting protein, ELIQUIS decreases thrombin generation and blood clot formation. ELIQUIS is approved for multiple indications in the U.S. based on efficacy and safety data from multiple Phase 3 clinical trials. ELIQUIS is a prescription medicine indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF); for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery; for the treatment of DVT and PE; and to reduce the risk of recurrent DVT and PE, following initial therapy. ELIQUIS continues to be developed and commercialized by The Bristol Myers Squibb-Pfizer Alliance. ELIQUIS Important Safety Information Indications ELIQUIS is indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. ELIQUIS is indicated for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. ELIQUIS is indicated for the treatment of DVT and PE, and to reduce the risk of recurrent DVT and PE following initial therapy. Important Safety Information WARNING: (A) PREMATURE DISCONTINUATION OF ELIQUIS INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA (A) Premature discontinuation of any oral anticoagulant, including ELIQUIS, increases the risk of thrombotic events. If anticoagulation with ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant. (B) Epidural or spinal hematomas may occur in patients treated with ELIQUIS who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants a history of traumatic or repeated epidural or spinal punctures a history of spinal deformity or spinal surgery optimal timing between the administration of ELIQUIS and neuraxial procedures is not known Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated. CONTRAINDICATIONS Active pathological bleeding Severe hypersensitivity reaction to ELIQUIS (e.g., anaphylactic reactions) WARNINGS AND PRECAUTIONS Increased Risk of Thrombotic Events after Premature Discontinuation: Premature discontinuation of any oral anticoagulant, including ELIQUIS, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. An increased rate of stroke was observed during the transition from ELIQUIS to warfarin in clinical trials in atrial fibrillation patients. If ELIQUIS is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant. Bleeding Risk: ELIQUIS increases the risk of bleeding and can cause serious, potentially fatal, bleeding. Concomitant use of drugs affecting hemostasis increases the risk of bleeding, including aspirin and other antiplatelet agents, other anticoagulants, heparin, thrombolytic agents, SSRIs, SNRIs, and NSAIDs. Advise patients of signs and symptoms of blood loss and to report them immediately or go to an emergency room. Discontinue ELIQUIS in patients with active pathological hemorrhage. The anticoagulant effect of apixaban can be expected to persist for at least 24 hours after the last dose (i.e., about two half-lives). An agent to reverse the anti-factor Xa activity of apixaban is available. Please visit for more information on availability of a specific reversal agent. Spinal/Epidural Anesthesia or Puncture: Patients treated with ELIQUIS undergoing spinal/epidural anesthesia or puncture may develop an epidural or spinal hematoma which can result in long-term or permanent paralysis. The risk of these events may be increased by the postoperative use of indwelling epidural catheters or the concomitant use of medicinal products affecting hemostasis. Indwelling epidural or intrathecal catheters should not be removed earlier than 24 hours after the last administration of ELIQUIS. The next dose of ELIQUIS should not be administered earlier than 5 hours after the removal of the catheter. The risk may also be increased by traumatic or repeated epidural or spinal puncture. If traumatic puncture occurs, delay the administration of ELIQUIS for 48 hours. Monitor patients frequently and if neurological compromise is noted, urgent diagnosis and treatment is necessary. Physicians should consider the potential benefit versus the risk of neuraxial intervention in ELIQUIS patients. Prosthetic Heart Valves: The safety and efficacy of ELIQUIS have not been studied in patients with prosthetic heart valves and is not recommended in these patients. Acute PE in Hemodynamically Unstable Patients or Patients who Require Thrombolysis or Pulmonary Embolectomy: Initiation of ELIQUIS is not recommended as an alternative to unfractionated heparin for the initial treatment of patients with PE who present with hemodynamic instability or who may receive thrombolysis or pulmonary embolectomy. Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome (APS): Direct-acting oral anticoagulants (DOACs), including ELIQUIS, are not recommended for use in patients with triple-positive APS. For patients with APS (especially those who are triple positive [positive for lupus anticoagulant, anticardiolipin, and anti–beta 2-glycoprotein I antibodies]), treatment with DOACs has been associated with increased rates of recurrent thrombotic events compared with vitamin K antagonist therapy. ADVERSE REACTIONS The most common and most serious adverse reactions reported with ELIQUIS were related to bleeding. TEMPORARY INTERRUPTION FOR SURGERY AND OTHER INTERVENTIONS ELIQUIS should be discontinued at least 48 hours prior to elective surgery or invasive procedures with a moderate or high risk of unacceptable or clinically significant bleeding. ELIQUIS should be discontinued at least 24 hours prior to elective surgery or invasive procedures with a low risk of bleeding or where the bleeding would be noncritical in location and easily controlled. Bridging anticoagulation during the 24 to 48 hours after stopping ELIQUIS and prior to the intervention is not generally required. ELIQUIS should be restarted after the surgical or other procedures as soon as adequate hemostasis has been established. DRUG INTERACTIONS Combined P-gp and Strong CYP3A4 Inhibitors: Inhibitors of P-glycoprotein (P-gp) and cytochrome P450 3A4 (CYP3A4) increase exposure to apixaban and increase the risk of bleeding. For patients receiving ELIQUIS doses of 5 mg or 10 mg twice daily, reduce the dose of ELIQUIS by 50% when ELIQUIS is coadministered with drugs that are combined P-gp and strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, or ritonavir). In patients already taking 2.5 mg twice daily, avoid coadministration of ELIQUIS with combined P-gp and strong CYP3A4 inhibitors. Clarithromycin Although clarithromycin is a combined P-gp and strong CYP3A4 inhibitor, pharmacokinetic data suggest that no dose adjustment is necessary with concomitant administration with ELIQUIS. Combined P-gp and Strong CYP3A4 Inducers: Avoid concomitant use of ELIQUIS with combined P-gp and strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort) because such drugs will decrease exposure to apixaban. Anticoagulants and Antiplatelet Agents: Coadministration of antiplatelet agents, fibrinolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. APPRAISE-2, a placebo-controlled clinical trial of apixaban in high-risk post-acute coronary syndrome patients treated with aspirin or the combination of aspirin and clopidogrel, was terminated early due to a higher rate of bleeding with apixaban compared to placebo. PREGNANCY The limited available data on ELIQUIS use in pregnant women are insufficient to inform drug-associated risks of major birth defects, miscarriage, or adverse developmental outcomes. Treatment may increase the risk of bleeding during pregnancy and delivery, and in the fetus and neonate. Labor or delivery: ELIQUIS use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. Consider use of a shorter acting anticoagulant as delivery approaches. LACTATION Breastfeeding is not recommended during treatment with ELIQUIS. FEMALES AND MALES OF REPRODUCTIVE POTENTIAL Females of reproductive potential requiring anticoagulation should discuss pregnancy planning with their physician. The risk of clinically significant uterine bleeding, potentially requiring gynecological surgical interventions, identified with oral anticoagulants including ELIQUIS should be assessed in these patients and those with abnormal uterine bleeding. Please see U.S. Full Prescribing Information, including Boxed WARNINGS, available at BMS.com. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram. About the Bristol Myers Squibb-Pfizer Collaboration The Bristol Myers Squibb-Pfizer Alliance (the Alliance) is committed to driving education and awareness about atrial fibrillation and deep vein thrombosis (DVT) and/or pulmonary embolism (PE). With long-standing cardiovascular leadership, global scale and expertise in this field, the Alliance strives to implement global, research-driven approaches to illuminate and address the unmet needs around strokes related to non-valvular atrial fibrillation, which are often fatal or debilitating. Through collaborations with non-profit organizations, the Alliance aims to provide patients, healthcare professionals and decision makers with the information they need to understand and take appropriate action on risk factors associated with stroke and other cardiovascular conditions. Cautionary Statement Regarding Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the results of future post-marketing studies will be consistent with the results of these studies, that CAMZYOS (mavacamten) or ELIQUIS (apixaban) may not be commercially successful, any marketing approvals, if granted, may have significant limitations on their use, and that continued approval of such products for such indications may be contingent upon verification and description of clinical benefit in additional confirmatory trials. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise. corporatefinancial-news

Product Sales Excluding Veklury Increased Year-Over-Year by 7% for Full Year 2023 Biktarvy Sales Increased Year-Over-Year by 14% for Full Year 2023 Oncology Sales Increased Year-Over-Year by 37% for Full Year 2023 FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the fourth quarter and full year 2023. “This was another strong year of revenue growth for Gilead’s base business, driven by both HIV and Oncology,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “The strength of the business provides a solid foundation as we enter a new catalyst-rich phase for the company. We are expecting several milestones in 2024, including updates on long-acting HIV prevention and treatment, Cell Therapy and Trodelvy.” Fourth Quarter 2023 Financial Results Total fourth quarter 2023 revenue decreased 4% to $7.1 billion compared to the same period in 2022, primarily due to lower Veklury® (remdesivir) and HIV sales, partially offset by higher Oncology sales. Diluted Earnings Per Share (“EPS”) decreased to $1.14 in the fourth quarter 2023 compared to $1.30 in the same period in 2022, primarily due to higher total costs and expenses, and lower Veklury revenues, partially offset by unrealized gains on equity investments in 2023 compared to losses in 2022, and lower tax expense. Non-GAAP diluted EPS increased to $1.72 in the fourth quarter 2023 compared to $1.67 in the same period in 2022, primarily due to lower total costs and expenses, partially offset by lower Veklury revenues. As of December 31, 2023, Gilead had $8.4 billion of cash, cash equivalents and marketable debt securities compared to $7.6 billion as of December 31, 2022. During the fourth quarter 2023, Gilead generated $2.2 billion in operating cash flow. During the fourth quarter 2023, Gilead paid cash dividends of $943 million and utilized $150 million to repurchase common stock. Fourth Quarter 2023 Product Sales Total fourth quarter 2023 product sales decreased 4% to $7.1 billion compared to the same period in 2022. Total product sales, excluding Veklury, of $6.3 billion were flat compared to the same period in 2022, with higher Oncology sales partially offset by lower HIV sales. HIV product sales decreased 2% to $4.7 billion in the fourth quarter 2023 compared to the same period in 2022, primarily driven by lower average realized price due to channel mix, partially offset by higher demand and channel inventory dynamics. Biktarvy® (bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 7% to $3.1 billion in the fourth quarter 2023 compared to the same period in 2022, primarily reflecting higher demand, partially offset by lower average realized price due to channel mix. Descovy® (FTC 200mg/TAF 25mg) sales decreased 5% to $509 million in the fourth quarter 2023 compared to the same period in 2022, primarily driven by unfavorable pricing dynamics in the United States, partially offset by higher demand and channel inventory dynamics. The Liver Disease portfolio sales were $691 million in the fourth quarter 2023 and remained flat compared to the same period in 2022. Sales were impacted by unfavorable pricing dynamics, offset by higher demand across chronic hepatitis C virus (“HCV”) and chronic hepatitis delta virus (“HDV”) products. Cell Therapy product sales increased 11% to $466 million in the fourth quarter 2023 compared to the same period in 2022. Yescarta® (axicabtagene ciloleucel) sales increased 9% to $368 million in the fourth quarter 2023 compared to the same period in 2022, primarily driven by strong demand in relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”) outside the United States. Tecartus® (brexucabtagene autoleucel) sales increased 19% to $98 million in the fourth quarter 2023 compared to the same period in 2022, driven by increased demand in R/R adult acute lymphoblastic leukemia (“ALL”) and in R/R mantle cell lymphoma (“MCL”). Trodelvy® (sacituzumab govitecan-hziy) sales increased 53% to $299 million in the fourth quarter 2023 compared to the same period in 2022, reflecting higher demand in both the United States and Europe. Veklury sales decreased 28% to $720 million in the fourth quarter 2023 compared to the same period in 2022, primarily driven by lower rates of COVID-19 related hospitalizations. Veklury sales generally reflect COVID-19 related rates and severity of infections and hospitalizations, as well as the availability, uptake and effectiveness of vaccinations and alternative treatments for COVID-19. Fourth Quarter 2023 Product Gross Margin, Operating Expenses and Tax Product gross margin was 70.4% in the fourth quarter 2023 compared to 81.0% in the same period in 2022, primarily driven by restructuring expenses related to changes in our manufacturing strategy, intangible asset amortization expenses related to Trodelvy following approval for pretreated HR+/HER2- metastatic breast cancer in February 2023, and product mix. Non-GAAP product gross margin was 86.1% in the fourth quarter 2023 compared to 86.8% in the same period in 2022, primarily driven by product mix. Research and development (“R&D”) expenses were $1.4 billion in the fourth quarter 2023 compared to $1.5 billion in the same period in 2022, driven by the timing of clinical activities and valuation adjustments to the MYR-related contingent consideration, partially offset by increased investments in Oncology. Non-GAAP R&D expenses were $1.5 billion in the fourth quarter 2023 and in the same period in 2022. Decreases due to the timing of clinical activities were offset by increased investments in Oncology. Acquired in-process research and development (“IPR&D”) expenses were $347 million in the fourth quarter 2023, primarily driven by payments related to collaborations with Arcellx, Inc. (“Arcellx”), Assembly Biosciences, Inc. (“Assembly”), and Compugen Ltd. (“Compugen”), as well as a milestone payment related to the acquisition of XinThera, Inc. (“XinThera”). Selling, general and administrative (“SG&A”) and non-GAAP SG&A expenses were $1.6 billion in the fourth quarter 2023 compared to $2.0 billion in the same period in 2022. The decrease was primarily driven by a 2022 charge related to the termination of the Trodelvy collaboration agreement with Everest Medicines (“Everest”) that did not repeat. The effective tax rate (“ETR”) was 14.3% in the fourth quarter 2023 compared to 19.6% in the same period in 2022, primarily due to remeasurement of certain deferred tax liabilities and non-taxable unrealized gains on equity investments. Non-GAAP ETR was 17.1% in the fourth quarter 2023 compared to 16.8% in the same period in 2022. Full Year 2023 Financial Results Total full year 2023 revenue decreased 1% to $27.1 billion compared to 2022, driven by a reduction of $1.7 billion in Veklury sales, largely offset by higher HIV and Oncology sales. Diluted EPS increased to $4.50 in the full year 2023 compared to $3.64 in 2022, primarily due to lower IPR&D impairment expenses, lower unrealized losses on equity investments, and higher interest income, partially offset by higher cost of goods sold and operating expenses, and lower Veklury sales. Non-GAAP diluted EPS decreased to $6.72 in the full year 2023 compared to $7.26 in 2022. This was primarily driven by higher total costs and expenses, as well as lower Veklury sales, partially offset by a decrease in tax reserves as a result of reaching an agreement with a tax authority, and higher interest income. Full Year 2023 Product Sales Total full year 2023 product sales of $26.9 billion were relatively flat compared to the same period in 2022, with lower Veklury sales largely offset by higher HIV and Oncology sales. Total product sales, excluding Veklury, increased 7% to $24.7 billion in the full year 2023 compared to 2022, primarily driven by higher HIV and Oncology sales. HIV product sales increased 6% to $18.2 billion in the full year 2023 compared to 2022, primarily reflecting higher demand across treatment and prevention, in addition to higher average realized price and favorable channel inventory dynamics. Biktarvy sales increased 14% to $11.8 billion in the full year 2023 compared to 2022, primarily reflecting higher demand as well as higher average realized price. Descovy sales increased 6% to $2.0 billion in the full year 2023 compared to 2022, primarily driven by favorable channel inventory dynamics and higher demand. The Liver Disease portfolio sales decreased 1% to $2.8 billion in the full year 2023 compared to 2022. The decrease was primarily driven by unfavorable HCV pricing dynamics and foreign exchange rates, partially offset by higher demand across HCV, HDV and chronic hepatitis B virus (“HBV”) products. Cell Therapy product sales increased 28% to $1.9 billion in the full year 2023 compared to 2022. Yescarta sales increased 29% to $1.5 billion in the full year 2023 compared to 2022, primarily driven by increased demand in R/R LBCL. Tecartus sales increased 24% to $370 million in the full year 2023 compared to 2022, primarily driven by increased demand in in R/R ALL and R/R MCL. Trodelvy sales increased 56% to $1.1 billion in the full year 2023 compared to 2022, reflecting strong demand in new and existing geographies. Veklury sales decreased 44% to $2.2 billion in the full year 2023 compared to 2022, primarily driven by lower rates of COVID-19 related hospitalizations in all regions. Full Year 2023 Product Gross Margin, Operating Expenses and Tax Product gross margin was 75.9% in the full year 2023 compared to 79.0% in 2022, primarily driven by restructuring expenses related to the aforementioned changes in our manufacturing strategy, increased amortization expenses, and product mix. Non-GAAP product gross margin was 86.3% in the full year 2023 compared to 86.6% in 2022, primarily driven by product mix. R&D and non-GAAP R&D expenses were $5.7 billion in the full year 2023 compared to $5.0 billion in 2022. This primarily reflects increased clinical activities across our Oncology and Virology programs. Acquired IPR&D expenses were $1.2 billion in the full year 2023, primarily driven by payments related to the collaboration with Arcellx, as well as the acquisition of XinThera and Tmunity Therapeutics Inc. (“Tmunity”). SG&A expenses were $6.1 billion in the full year 2023 compared to $5.7 billion in 2022. Non-GAAP SG&A expenses were $6.1 billion in the full year 2023 compared to $5.6 billion in 2022. The increases in SG&A and non-GAAP SG&A expenses are primarily due to a $525 million litigation settlement with certain plaintiffs in the HIV antitrust litigation and increased commercial activities in Oncology and HIV, partially offset by the 2022 charge related to the termination of the Trodelvy collaboration agreement with Everest. The ETR and non-GAAP ETR were 18.2% and 15.2%, respectively, in the full year 2023 compared to 21.5% and 19.3%, respectively, in 2022. Lower ETR is primarily due to a decrease in tax reserves as a result of reaching agreement with a tax authority on certain tax positions. Guidance and Outlook Gilead is providing full-year 2024 guidance below: Total product sales between $27.1 billion and $27.5 billion. Total product sales, excluding Veklury, between $25.8 billion and $26.2 billion. Total Veklury sales of approximately $1.3 billion. Diluted EPS between $5.15 and $5.55. Non-GAAP diluted EPS between $6.85 and $7.25. Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2024 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below. Key Updates Since Our Last Quarterly Release Virology Announced that the Phase 3 OAKTREE trial of obeldesivir in non-hospitalized participants without risk factors for developing severe COVID-19 did not meet its primary endpoint of improvement in time to symptom alleviation. Obeldesivir was well-tolerated in this large study population. Oncology Announced that the Phase 3 EVOKE-01 study of Trodelvy versus docetaxel in previously treated metastatic non-small cell lung cancer did not meet its primary endpoint of overall survival. While not statistically powered, we observed an encouraging trend in a subgroup of patients non-responsive to prior anti-PD-(L)1 immunotherapy, that we may potentially explore further. Presented new data at the San Antonio Breast Cancer Symposium 2023, including a post-hoc, subgroup analysis of clinical outcomes by age from the Phase 3 TROPiCS-02 study of Trodelvy in HR+/HER2- metastatic breast cancer. Presented new data at the American Society of Hematology 2023 Annual Meeting (“ASH”) including long-term follow-up across Yescarta trials in R/R LBCL, first-line high-risk LBCL, and R/R follicular lymphoma, as well as real-world data for Tecartus in R/R MCL and B-cell ALL. Received U.S. Food and Drug Administration (“FDA”) approval of Yescarta’s label update to include overall survival (“OS”) data from the Phase 3 ZUMA-7 study, which showed a statistically significant OS improvement for Yescarta in second-line R/R LBCL versus standard of care. Received FDA approval of a manufacturing process change resulting in reduced median turnaround time for Yescarta in the U.S. to an anticipated 14 days (from 16 days previously). Our partner Arcellx presented updated data at ASH from the Phase 1 trial evaluating anitocabtagene autoleucel (“anito-cel”) in R/R multiple myeloma. With 26.5 months of median follow-up, the data demonstrated continued deep and durable responses, including in patients with extramedullary disease, with median progression-free survival not reached. In addition, no cases of delayed neurotoxicity events or parkinsonian symptoms were observed. Announced expansion of the Arcellx collaboration to include exercising an option for the ARC-SparX ACLX-001 program in multiple myeloma, expanding the scope of the existing anito-cel collaboration to include lymphomas, and a further equity investment of $200 million. Announced an amended collaboration agreement with Arcus Biosciences, Inc. (“Arcus”), including an update to the domvanalimab development collaboration program, and an additional $320 million equity investment. Announced an exclusive license agreement with Compugen for later-stage development and commercialization of novel pre-clinical anti-IL18 binding protein antibodies, including COM503, that have the potential to treat various tumor types. Corporate Announced that Ted Love has joined Gilead’s Board of Directors. Named to Dow Jones Sustainability World Index for third consecutive year and added to the North America Index for the first year, reflecting Gilead’s ongoing commitment to corporate responsibility and sustainability. The company’s Board of Directors declared a quarterly dividend of $0.77 per share of common stock for the first quarter of 2024. The dividend is payable on March 28, 2024, to stockholders of record at the close of business on March 15, 2024. Future dividends will be subject to Board approval. Certain amounts and percentages in this press release may not sum or recalculate due to rounding. Conference Call At 2:00 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on and will be archived on for one year. Non-GAAP Financial Information The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets and inventory step-up charges, and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with changes in tax related laws and guidelines. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include those relating to: Gilead’s ability to achieve its anticipated full year 2024 financial results, including as a result of the uncertainty of the amount and timing of Veklury revenues; Gilead’s ability to make progress on any of its long-term ambitions or strategic priorities laid out in its corporate strategy; Gilead’s ability to accelerate or sustain revenues for its virology, oncology and other programs; Gilead’s ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements, including the arrangements with Arcellx, Arcus, Assembly, Compugen, Galapagos NV, MYR, Tmunity, and XinThera; patent protection and estimated loss of exclusivity for our products and product candidates; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timeframes or at all, the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Tecartus, Trodelvy (including EVOKE-01), Yescarta, anito-cel and domvanalimab, and the risk that safety and efficacy data from clinical trials may not warrant further development of Gilead’s product candidates or the product candidates of Gilead’s strategic partners; Gilead’s ability to submit new drug applications for new product candidates or expanded indications in the currently anticipated timelines; Gilead’s ability to receive regulatory approvals in a timely manner or at all, and the risk that any such approvals, if granted, may be subject to significant limitations on use; Gilead’s ability to successfully commercialize its products; the risk of potential disruptions to the manufacturing and supply chain of Gilead’s products; pricing and reimbursement pressures from government agencies and other third parties, including required rebates and other discounts; a larger than anticipated shift in payer mix to more highly discounted payer segments; market share and price erosion caused by the introduction of generic versions of Gilead products; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products, including Yescarta; and other risks identified from time to time in Gilead’s reports filed with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. There may be other factors of which Gilead is not currently aware that may affect matters discussed in the forward-looking statements and may also cause actual results to differ significantly from these estimates. Further, results for the quarter ended December 31, 2023 are not necessarily indicative of operating results for any future periods. Gilead directs readers to its press releases, annual reports on Form 10-K, quarterly reports on Form 10-Q and other subsequent disclosure documents filed with the SEC. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The reader is cautioned that forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update or supplement any such forward-looking statements other than as required by law. Any forward-looking statements speak only as of the date hereof or as of the dates indicated in the statements. Gilead owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD®, GILEAD SCIENCES®, KITE™, AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX®, HEPSERA®, JYSELECA®, LETAIRIS®, ODEFSEY®, SOVALDI®, STRIBILD®, SUNLENCA® , TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA® and ZYDELIG®. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, United States. Other trademarks are the property of their respective owners. For more information on Gilead Sciences, Inc., please visit or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235). GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except per share amounts) 2023 2022 2023 2022 Revenues: Product sales $ 7,070 $ 7,333 $ 26,934 $ 26,982 Royalty, contract and other revenues 45 56 182 299 Total revenues 7,115 7,389 27,116 27,281 Costs and expenses: Cost of goods sold 2,090 1,396 6,498 5,657 Research and development expenses 1,408 1,548 5,718 4,977 Acquired in-process research and development expenses 347 158 1,155 944 In-process research and development impairment 50 — 50 2,700 Selling, general and administrative expenses 1,608 2,020 6,090 5,673 Total costs and expenses 5,503 5,122 19,511 19,951 Operating income 1,612 2,267 7,605 7,330 Interest expense (252 ) (227 ) (944 ) (935 ) Other income (expense), net 293 (9 ) 198 (581 ) Income before income taxes 1,653 2,031 6,859 5,814 Income tax expense (236 ) (398 ) (1,247 ) (1,248 ) Net income 1,417 1,633 5,613 4,566 Net loss attributable to noncontrolling interest 12 7 52 26 Net income attributable to Gilead $ 1,429 $ 1,640 $ 5,665 $ 4,592 Basic earnings per share attributable to Gilead $ 1.15 $ 1.31 $ 4.54 $ 3.66 Shares used in basic earnings per share attributable to Gilead calculation 1,248 1,252 1,248 1,255 Diluted earnings per share attributable to Gilead $ 1.14 $ 1.30 $ 4.50 $ 3.64 Shares used in diluted earnings per share attributable to Gilead calculation 1,256 1,264 1,258 1,262 Cash dividends declared per share $ 0.75 $ 0.73 $ 3.00 $ 2.92 Research and development expenses as a % of revenues 19.8 % 20.9 % 21.1 % 18.2 % Selling, general and administrative expenses as a % of revenues 22.6 % 27.3 % 22.5 % 20.8 % GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages) 2023 2022 Change 2023 2022 Change Product sales: HIV $ 4,693 $ 4,772 (2 )% $ 18,175 $ 17,194 6 % Oncology 765 614 24 % 2,932 2,139 37 % Liver Disease 691 694 — % 2,784 2,798 (1 )% Other 201 252 (20 )% 859 946 (9 )% Total product sales excluding Veklury 6,350 6,333 — % 24,750 23,077 7 % Veklury 720 1,000 (28 )% 2,184 3,905 (44 )% Total product sales 7,070 7,333 (4 )% 26,934 26,982 — % Royalty, contract and other revenues 45 56 (21 )% 182 299 (39 )% Total revenues $ 7,115 $ 7,389 (4 )% $ 27,116 $ 27,281 (1 )% GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION(1) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages) 2023 2022 Change 2023 2022 Change Non-GAAP: Cost of goods sold $ 980 $ 968 1 % $ 3,697 $ 3,602 3 % Research and development expenses $ 1,452 $ 1,544 (6 )% $ 5,720 $ 4,968 15 % Acquired IPR&D expenses(2) $ 347 $ 158 NM $ 1,155 $ 944 22 % Selling, general and administrative expenses $ 1,597 $ 2,020 (21 )% $ 6,060 $ 5,587 8 % Other income (expense), net $ 104 $ 52 NM $ 365 $ 77 NM Diluted EPS $ 1.72 $ 1.67 3 % $ 6.72 $ 7.26 (7 )% Product gross margin 86.1 % 86.8 % -66 bps 86.3 % 86.6 % -38 bps Research and development expenses as a % of revenues 20.4 % 20.9 % -49 bps 21.1 % 18.2 % 288 bps Selling, general and administrative expenses as a % of revenues 22.4 % 27.3 % -490 bps 22.3 % 20.5 % 187 bps Operating margin 38.5 % 36.5 % 197 bps 38.7 % 44.6 % -598 bps Effective tax rate 17.1 % 16.8 % 22 bps 15.2 % 19.3 % -416 bps ________________________________ NM - Not Meaningful (1) Refer to Non-GAAP Financial Information section above for further disclosures on non-GAAP financial measures. A reconciliation between GAAP and non-GAAP financial information is provided in the tables below. (2) Equal to GAAP financial information. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages and per share amounts) 2023 2022 2023 2022 Cost of goods sold reconciliation: GAAP cost of goods sold $ 2,090 $ 1,396 $ 6,498 $ 5,657 Acquisition-related – amortization(1) (580 ) (428 ) (2,271 ) (2,013 ) Restructuring . (479 ) — (479 ) (42 ) Other(2) (51 ) — (51 ) — Non-GAAP cost of goods sold $ 980 $ 968 $ 3,697 $ 3,602 Product gross margin reconciliation: GAAP product gross margin 70.4 % 81.0 % 75.9 % 79.0 % Acquisition-related – amortization(1) 8.2 % 5.8 % 8.4 % 7.5 % Restructuring . 6.8 % — % 1.8 % 0.2 % Other(2) 0.7 % — % 0.2 % — % Non-GAAP product gross margin 86.1 % 86.8 % 86.3 % 86.6 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,408 $ 1,548 $ 5,718 $ 4,977 Acquisition-related – other costs(4) 59 (1 ) 22 13 Restructuring . (15 ) . (4 ) (20 ) (22 ) Non-GAAP research and development expenses $ 1,452 $ 1,544 $ 5,720 $ 4,968 IPR&D impairment reconciliation: GAAP IPR&D impairment $ 50 $ — $ 50 $ 2,700 IPR&D impairment (50 ) — (50 ) (2,700 ) Non-GAAP IPR&D impairment $ — $ — $ — $ — Selling, general and administrative expenses reconciliation: GAAP selling, general and administrative expenses $ 1,608 $ 2,020 $ 6,090 $ 5,673 Acquisition-related – other costs(4) — (1 ) (2 ) (3 ) Restructuring (11 ) . 1 (28 ) 2 Other(3) — — — (85 ) Non-GAAP selling, general and administrative expenses $ 1,597 $ 2,020 $ 6,060 $ 5,587 Operating income reconciliation: GAAP operating income $ 1,612 $ 2,267 $ 7,605 $ 7,330 Acquisition-related – amortization(1) 580 428 2,271 2,013 Acquisition-related – other costs(4) (59 ) . 2 (20 ) (10 ) Restructuring 505 . 2 527 62 IPR&D impairment 50 . — 50 2,700 Other(2)(3) 51 — 51 85 Non-GAAP operating income $ 2,739 $ 2,699 $ 10,484 $ 12,180 Operating margin reconciliation: GAAP operating margin 22.7 % 30.7 % 28.0 % 26.9 % Acquisition-related – amortization(1) 8.1 % 5.8 % 8.4 % 7.4 % Acquisition-related – other costs(4) (0.8 ) % — % (0.1 ) % — % Restructuring . 7.1 % — % 1.9 % 0.2 % IPR&D impairment 0.7 % — % 0.2 % 9.9 % Other(2)(3) 0.7 % — % 0.2 % 0.3 % Non-GAAP operating margin 38.5 % 36.5 % 38.7 % 44.6 % Other income (expense), net reconciliation: GAAP other income (expense), net $ 293 $ (9 ) $ 198 $ (581 ) (Gain) loss from equity securities, net (189 ) 61 167 657 Non-GAAP other income (expense), net $ 104 $ 52 $ 365 $ 77 GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions, except percentages and per share amounts) 2023 2022 2023 2022 Effective tax rate reconciliation: GAAP effective tax rate 14.3 % 19.6 % 18.2 % 21.5 % Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments(5) 2.8 % (2.8 ) % (3.0 ) % (2.1 ) % Non-GAAP effective tax rate 17.1 % 16.8 % 15.2 % 19.3 % Net income attributable to Gilead reconciliation: GAAP net income attributable to Gilead $ 1,429 $ 1,640 $ 5,665 $ 4,592 Acquisition-related – amortization(1) 460 346 1,805 1,610 Acquisition-related – other costs(4) (59 ) 1 (29 ) (12 ) Restructuring 414 . 2 431 47 IPR&D impairment 35 — 35 2,057 (Gain) loss from equity securities, net (171 ) 60 180 630 Discrete and related tax charges(5) 12 57 326 175 Other(2)(3) 40 — 40 59 Non-GAAP net income attributable to Gilead $ 2,161 $ 2,106 $ 8,454 $ 9,158 Diluted earnings per share reconciliation: GAAP diluted earnings per share $ 1.14 $ 1.30 $ 4.50 $ 3.64 Acquisition-related – amortization(1) 0.37 0.27 1.43 1.28 Acquisition-related – other costs(4) (0.05 ) — (0.02 ) (0.01 ) Restructuring . 0.33 — 0.34 0.04 IPR&D impairment 0.03 — 0.03 1.63 (Gain) loss from equity securities, net (0.14 ) 0.05 0.14 0.50 Discrete and related tax charges(5) 0.01 0.05 0.26 0.14 Other(2)(3) 0.03 — 0.03 0.05 Non-GAAP diluted earnings per share $ 1.72 $ 1.67 $ 6.72 $ 7.26 Non-GAAP adjustment summary: Cost of goods sold adjustments $ 1,110 $ 428 $ 2,801 $ 2,055 Research and development expenses adjustments (44 ) 4 (2 ) 9 IPR&D impairment adjustments 50 — 50 2,700 Selling, general and administrative expenses adjustments 11 — 30 86 Total non-GAAP adjustments to costs and expenses 1,127 432 2,879 4,850 Other income (expense), net, adjustments (189 ) 61 167 657 Total non-GAAP adjustments before income taxes 938 493 3,046 5,507 Income tax effect of non-GAAP adjustments above (218 ) (84 ) (583 ) (1,116 ) Discrete and related tax charges(5) 12 57 326 175 Total non-GAAP adjustments to net income attributable to Gilead $ 732 $ 466 $ 2,789 $ 4,566 ______________________________ (1) Relates to amortization of acquired intangibles and inventory step-up charges. (2) Relates to a write-off of an intangible asset related to the restructuring of our collaboration with Galapagos NV during the fourth quarter of 2023. (3) Relates to donations to the Gilead Foundation, a California nonprofit organization, during the second quarter of 2022. (4) Adjustments include integration expenses, contingent consideration fair value adjustments and other expenses associated with Gilead’s acquisitions of MYR GmbH, MiroBio, Ltd., Tmunity Therapeutics, Inc. and XinThera, Inc. (5) Represents discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP 2024 FULL YEAR GUIDANCE(1) (unaudited) (in millions, except percentages and per share amounts) Provided February 6, 2024 Projected product gross margin GAAP to non-GAAP reconciliation: GAAP projected product gross margin 76.0% - 77.0% Acquisition-related expenses and other ~ 9.0% Non-GAAP projected product gross margin 85.0% - 86.0% Projected operating income GAAP to non-GAAP reconciliation: GAAP projected operating income $8,700 - $9,200 Acquisition-related expenses and other ~ 2,500 Non-GAAP projected operating income $11,200 - $11,700 Projected effective tax rate GAAP to non-GAAP reconciliation: GAAP projected effective tax rate ~ 21% Income tax effect of above non-GAAP adjustments, and discrete and related tax adjustments (~ 2%) Non-GAAP projected effective tax rate ~ 19% Projected diluted EPS GAAP to non-GAAP reconciliation: GAAP projected diluted EPS $5.15 - $5.55 Acquisition-related expenses and other, and discrete and related tax adjustments ~ 1.70 Non-GAAP projected diluted EPS $6.85 - $7.25 ________________________________ (1) Our full-year guidance excludes the potential impact of any (i) acquisitions or business development transactions that have not been executed, (ii) future fair value adjustments of equity securities and (iii) discrete tax charges or benefits associated with changes in tax related laws and guidelines that have not been enacted, as Gilead is unable to project such amounts. The non-GAAP full-year guidance includes non-GAAP adjustments to actual current period results as well as adjustments for the known future impact associated with events that have already occurred, such as future amortization of our intangible assets and the future impact of discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States. GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) December 31, (in millions) 2023 2022 Assets Cash, cash equivalents and marketable debt securities $ 8,428 $ 7,630 Accounts receivable, net 4,660 4,777 Inventories 3,366 2,820 Property, plant and equipment, net 5,317 5,475 Intangible assets, net 26,454 28,894 Goodwill 8,314 8,314 Other assets 5,586 5,262 Total assets $ 62,125 $ 63,171 Liabilities and Stockholders’ Equity Current liabilities $ 11,280 $ 11,237 Long-term liabilities 28,096 30,725 Stockholders’ equity(1) 22,749 21,209 Total liabilities and stockholders’ equity $ 62,125 $ 63,171 ________________________________ (1) As of December 31, 2023 and 2022, there were 1,246 and 1,247 shares of common stock issued and outstanding, respectively. GILEAD SCIENCES, INC. SELECTED CASH FLOW INFORMATION (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2023 2022 2023 2022 Net cash provided by operating activities $ 2,168 $ 2,566 $ 8,006 $ 9,072 Net cash used in investing activities (726 ) (374 ) (2,265 ) (2,466 ) Net cash used in financing activities (1,100 ) (1,554 ) (5,125 ) (6,469 ) Effect of exchange rate changes on cash and cash equivalents 37 75 57 (63 ) Net change in cash and cash equivalents 380 713 673 74 Cash and cash equivalents at beginning of period 5,705 4,699 5,412 5,338 Cash and cash equivalents at end of period $ 6,085 $ 5,412 $ 6,085 $ 5,412 Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2023 2022 2023 2022 Net cash provided by operating activities $ 2,168 $ 2,566 $ 8,006 $ 9,072 Capital expenditures (214 ) (181 ) (585 ) (728 ) Free cash flow(1) $ 1,954 $ 2,386 $ 7,421 $ 8,344 ________________________________ (1) Free cash flow is a non-GAAP liquidity measure. Please refer to our disclosures in the Non-GAAP Financial Information section above. GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2023 2022 2023 2022 HIV Biktarvy – U.S. $ 2,588 $ 2,423 $ 9,692 $ 8,510 Biktarvy – Europe 333 295 1,253 1,103 Biktarvy – Other International 188 200 905 777 3,109 2,918 11,850 10,390 Complera / Eviplera – U.S. 6 17 47 74 Complera / Eviplera – Europe 15 37 70 113 Complera / Eviplera – Other International 3 3 12 13 24 58 129 200 Descovy – U.S. 457 479 1,771 1,631 Descovy – Europe 25 26 100 118 Descovy – Other International 28 31 114 123 509 537 1,985 1,872 Genvoya – U.S. 447 543 1,752 1,983 Genvoya – Europe 48 64 205 284 Genvoya – Other International 22 33 103 136 517 640 2,060 2,404 Odefsey – U.S. 258 295 1,012 1,058 Odefsey – Europe 71 85 294 364 Odefsey – Other International 11 11 44 47 340 392 1,350 1,469 Stribild – U.S. 15 20 72 88 Stribild – Europe 5 7 21 29 Stribild – Other International 2 3 8 10 22 29 101 127 Truvada – U.S. 12 37 82 113 Truvada – Europe 3 3 13 15 Truvada – Other International 3 5 19 18 18 45 114 147 Revenue share – Symtuza(1) – U.S. 104 97 382 348 Revenue share – Symtuza(1) – Europe 32 42 133 168 Revenue share – Symtuza(1) – Other International 3 3 13 14 139 142 529 530 Other HIV(2) – U.S. 13 4 37 15 Other HIV(2) – Europe 1 5 12 24 Other HIV(2) – Other International 1 3 7 17 15 12 56 57 Total HIV – U.S. 3,899 3,914 14,848 13,820 Total HIV – Europe 533 566 2,102 2,219 Total HIV – Other International 261 293 1,226 1,155 $ 4,693 $ 4,772 $ 18,175 $ 17,194 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2023 2022 2023 2022 Oncology Cell Therapy Tecartus – U.S. $ 66 $ 61 $ 245 $ 221 Tecartus – Europe 27 19 110 75 Tecartus – Other International 5 1 15 3 98 82 370 299 Yescarta – U.S. 187 219 811 747 Yescarta – Europe 140 103 547 355 Yescarta – Other International 42 15 140 57 368 337 1,498 1,160 Total Cell Therapy – U.S. 253 281 1,055 968 Total Cell Therapy – Europe 167 122 658 430 Total Cell Therapy – Other International 46 17 156 60 466 419 1,869 1,459 Trodelvy Trodelvy – U.S. 226 146 777 525 Trodelvy– Europe 48 44 217 143 Trodelvy – Other International 24 4 68 12 299 195 1,063 680 Total Oncology – U.S. 479 427 1,833 1,494 Total Oncology – Europe 216 166 875 573 Total Oncology – Other International 70 21 224 73 765 614 2,932 2,139 Liver Disease HCV Ledipasvir / Sofosbuvir(3) – U.S. 11 19 39 46 Ledipasvir / Sofosbuvir(3) – Europe 1 4 12 17 Ledipasvir / Sofosbuvir(3) – Other International 5 8 19 51 17 31 70 115 Sofosbuvir / Velpatasvir(4) – U.S. 216 214 859 844 Sofosbuvir / Velpatasvir(4) – Europe 74 67 323 355 Sofosbuvir / Velpatasvir(4) – Other International 89 87 355 331 378 369 1,537 1,530 Other HCV(5) – U.S. 25 27 104 115 Other HCV(5) – Europe 10 9 43 40 Other HCV(5) – Other International 3 3 12 10 37 39 160 166 Total HCV – U.S. 251 260 1,002 1,005 Total HCV – Europe 84 80 378 413 Total HCV – Other International 97 98 386 392 $ 432 $ 439 $ 1,767 $ 1,810 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended Twelve Months Ended December 31, December 31, (in millions) 2023 2022 2023 2022 HBV/HDV Vemlidy – U.S. $ 115 $ 123 $ 410 $ 429 Vemlidy – Europe 10 8 38 35 Vemlidy – Other International 92 89 414 379 217 220 862 842 Viread – U.S. 4 2 8 6 Viread – Europe 6 6 22 23 Viread – Other International 12 14 52 62 21 22 83 91 Other HBV/HDV(6) – U.S. — (1 ) — — Other HBV/HDV(6) – Europe 22 14 72 55 22 13 72 55 Total HBV/HDV – U.S. 119 124 418 435 Total HBV/HDV – Europe 37 28 133 112 Total HBV/HDV – Other International 103 103 466 441 259 255 1,017 988 Total Liver Disease – U.S. 370 384 1,421 1,440 Total Liver Disease – Europe 121 108 511 525 Total Liver Disease – Other International 200 202 852 833 691 694 2,784 2,798 Veklury Veklury – U.S. 364 395 972 1,575 Veklury – Europe 181 142 408 702 Veklury – Other International 175 462 805 1,628 720 1,000 2,184 3,905 Other AmBisome – U.S. 4 9 43 57 AmBisome – Europe 68 66 260 258 AmBisome – Other International 39 42 189 182 111 117 492 497 Letairis – U.S. 36 60 142 196 Other(7) – U.S. 28 44 118 135 Other(7) – Europe 9 13 40 65 Other(7) – Other International 17 18 66 53 54 75 225 253 Total Other – U.S. 68 113 304 388 Total Other – Europe 77 79 301 323 Total Other – Other International 56 61 255 235 201 252 859 946 Total product sales – U.S. 5,180 5,234 19,377 18,716 Total product sales – Europe 1,128 1,061 4,197 4,342 Total product sales – Other International 762 1,037 3,361 3,924 $ 7,070 $ 7,333 $ 26,934 $ 26,982 _______________________________ (1) Represents Gilead’s revenue from cobicistat (“C”), FTC and TAF in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company. (2) Includes Atripla, Emtriva, Sunlenca and Tybost. (3) Amounts consist of sales of Harvoni and the authorized generic version of Harvoni sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC. (4) Amounts consist of sales of Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC. (5) Includes Vosevi and Sovaldi. (6) Includes Hepcludex and Hepsera. (7) Includes Cayston, Jyseleca, Ranexa and Zydelig.